Value of MRCP+ And Liver Multiscan in the Management of Dominant Strictures in Primary Sclerosing Cholangitis

Summary

Primary sclerosing cholangitis (PSC) is a chronic progressive biliary disease. Due to the heterogeneous disease course and the relatively low clinical event rate of 5% per year it is difficult to predict prognosis of individual patients. Novel imaging techniques called MRCP+ and Liver Multiscan (LMS) hold the prospect of adequate depicting and quantifying lesions of the biliary tree as well as capturing functional derailment. However, these features must be tested first.

The purpose of this study is to assess the (i) ability of MRCP+ to detect change in biliary volume, (ii) reproducibility of MRCP+ and LMS, and (iii) correlation of MRCP+ with ERC findings as gold standard.

Conditions

• PSC
• MRI

Interventions

DIAGNOSTIC_TEST

Liver Multiscan sequences baseline

Additional Liver Multiscan sequences at baseline besides standard care MRI liver /MRCP prior to ERCP.

DEVICE

MRCP+ analysis baseline

Post processing tool (Software) for quantifying MRCP images after MRCP is performed. Patient involvement is not necessary during this procedure.

DEVICE

Liver Multiscan analysis baseline

Post processing tool (Software) for determining the corrected T1 time after the additional LMS sequences at baseline are performed. This cT1 reflects the activity of inflammation/fibrosis of the liver. Patient involvement is not necessary during this procedure.

DIAGNOSTIC_TEST

MRI liver with MRCP

An extra MRI liver with contrast and MRCP is performed 8 weeks after the ERCP following standard care protocol

DIAGNOSTIC_TEST

Liver Multiscan sequences follow-up

Additional Liver Multiscan sequences are performed at 8 weeks after ERCP.

DEVICE

MRCP+ analysis follow up

Post processing tool (Software) for quantifying MRCP images after the MRCP from follow up is performed. Patient involvement is not necessary during this procedure.

DEVICE

Liver Multiscan analysis follow up

Post processing tool (Software) for determining the corrected T1 time after the additional LMS sequences from the follow up scan are performed. This cT1 reflects the activity of inflammation/fibrosis of the liver. Patient involvement is not necessary during this procedure.

Sponsors & Collaborators

• Perspectum

  collaborator INDUSTRY

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  lead OTHER

Principal Investigators

• Cyriel Ponsioen, MD PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-01

Primary Completion

2023-05-31

Completion

2023-12-31

FDA Device

Yes